THRIVE Ventilation for Operative Hysteroscopy Under General Anesthesia

NCT05291117 | Completed

• 1 other identifier: 4631
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) allows to extend the apnoeic window in patients undergoing general anesthesia by delivering 100% of heated and humidified oxygen at 70L/min in order to maintain viable gas exchange during an extended period of cessation of spontaneous ventilation. This technique has been successfully applied in several clinical settings (induction of general anesthesia, laryngoscopy in predicted difficult airway management, and as unique airway management technique for procedural sedation or general anesthesia for brief surgical procedures). Operative hysteroscopy is a brief surgical procedure usually performed under general anesthesia with intravenous agents (propofol plus fentanyl) and positive pressure ventilation through facial or laryngeal mask. The aim of this study is to investigate the effects of THRIVE apnoeic ventilation during hysteroscopy under general anesthesia. Our primary outcome is to describe the trend of SpO2 and tcCO2 during the procedures. Secondary outcomes include description of arrhythmias requiring medical treatment, hemodynamic instability, unmanageable copious secretions, airway obstruction or inability to maintain airway patency, witnessed aspiration, airway related complications, number of airway manipulations, adverse events, assessment of postoperative dyspnoea and comfort, patient satisfaction. Women (\> 18 years old and \< 70 years old), ASA physical status I and II presenting for elective operative hysteroscopies will be included. A number of 30 patients was planned to target the primary outcome.

Conditions

Oxygen; General Anesthesia; Hysteroscopy

Keywords

Transnasal humified high flow oxygen

Outcome Measures

Primary Outcomes (2)

• change of tCO2 during THRIVE ventilation.

  CO2 values (reported as mmHg) measured by Radiometer monitor.

  pre-anesthesia; up to 1 hour.

• change of SpO2 during THRIVE ventilation.

  SpO2 values (reported as "%") measured by oxymeter.

  pre-anesthesia; up to 1 hour.

Secondary Outcomes (4)

• Airway related complications.

  2 hours after the end of anesthesia.

• Postoperative complications - 1

  2 hours after the end of anesthesia.

• Postoperative complications - 2

  2 hours after the end of anesthesia.

• Postoperative complications - 3

  2 hours after the end of anesthesia.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Patients undergoing operative hysteroscopy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women scheduled for elective operative hysteroscopies will be included.

You may qualify if:

• ASA I-II.

You may not qualify if:

• BMI \> 30,
• pregnancy,
• cardiac arrhythmia,
• high risk of aspiration,
• neuromuscular disease,
• patient refusal.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

IRCCS Policlinico Agostino Gemelli

Rome, 00168, Italy

Location

Related Publications (19)

• BARTLETT RG Jr, BRUBACH HF, SPECHT H. Demonstration of aventilatory mass flow during ventilation and apnea in man. J Appl Physiol. 1959 Jan;14(1):97-101. doi: 10.1152/jappl.1959.14.1.97. No abstract available.

  PMID: 13630833 RESULT

• Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.

  PMID: 25388828 RESULT

• O'Cain CF, Dowling NB, Slutsky AS, Hensley MJ, Strohl KP, McFadden ER Jr, Ingram RH Jr. Airway effects of respiratory heat loss in normal subjects. J Appl Physiol Respir Environ Exerc Physiol. 1980 Nov;49(5):875-80. doi: 10.1152/jappl.1980.49.5.875.

  PMID: 7429910 RESULT

• Slutsky AS, Brown R. Cardiogenic oscillations: a potential mechanism enhancing oxygenation during apneic respiration. Med Hypotheses. 1982 Apr;8(4):393-400. doi: 10.1016/0306-9877(82)90032-9.

  PMID: 6808323 RESULT

• Hermez LA, Spence CJ, Payton MJ, Nouraei SAR, Patel A, Barnes TH. A physiological study to determine the mechanism of carbon dioxide clearance during apnoea when using transnasal humidified rapid insufflation ventilatory exchange (THRIVE). Anaesthesia. 2019 Apr;74(4):441-449. doi: 10.1111/anae.14541. Epub 2019 Feb 15.

  PMID: 30767199 RESULT

• Hernandez G, Roca O, Colinas L. High-flow nasal cannula support therapy: new insights and improving performance. Crit Care. 2017 Mar 21;21(1):62. doi: 10.1186/s13054-017-1640-2.

  PMID: 28320436 RESULT

• Roca O, Riera J, Torres F, Masclans JR. High-flow oxygen therapy in acute respiratory failure. Respir Care. 2010 Apr;55(4):408-13.

  PMID: 20406507 RESULT

• Vourc'h M, Asfar P, Volteau C, Bachoumas K, Clavieras N, Egreteau PY, Asehnoune K, Mercat A, Reignier J, Jaber S, Prat G, Roquilly A, Brule N, Villers D, Bretonniere C, Guitton C. High-flow nasal cannula oxygen during endotracheal intubation in hypoxemic patients: a randomized controlled clinical trial. Intensive Care Med. 2015 Sep;41(9):1538-48. doi: 10.1007/s00134-015-3796-z. Epub 2015 Apr 14.

  PMID: 25869405 RESULT

• Parke RL, Bloch A, McGuinness SP. Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers. Respir Care. 2015 Oct;60(10):1397-403. doi: 10.4187/respcare.04028. Epub 2015 Sep 1.

  PMID: 26329355 RESULT

• Chikata Y, Onodera M, Oto J, Nishimura M. FIO2 in an Adult Model Simulating High-Flow Nasal Cannula Therapy. Respir Care. 2017 Feb;62(2):193-198. doi: 10.4187/respcare.04963. Epub 2016 Nov 22.

  PMID: 27879385 RESULT

• Moller W, Feng S, Domanski U, Franke KJ, Celik G, Bartenstein P, Becker S, Meyer G, Schmid O, Eickelberg O, Tatkov S, Nilius G. Nasal high flow reduces dead space. J Appl Physiol (1985). 2017 Jan 1;122(1):191-197. doi: 10.1152/japplphysiol.00584.2016. Epub 2016 Nov 17.

  PMID: 27856714 RESULT

• Gustafsson IM, Lodenius A, Tunelli J, Ullman J, Jonsson Fagerlund M. Apnoeic oxygenation in adults under general anaesthesia using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) - a physiological study. Br J Anaesth. 2017 Apr 1;118(4):610-617. doi: 10.1093/bja/aex036.

  PMID: 28403407 RESULT

• Wong DT, Dallaire A, Singh KP, Madhusudan P, Jackson T, Singh M, Wong J, Chung F. High-Flow Nasal Oxygen Improves Safe Apnea Time in Morbidly Obese Patients Undergoing General Anesthesia: A Randomized Controlled Trial. Anesth Analg. 2019 Oct;129(4):1130-1136. doi: 10.1213/ANE.0000000000003966.

  PMID: 31584919 RESULT

• Mazzeffi MA, Petrick KM, Magder L, Greenwald BD, Darwin P, Goldberg EM, Bigeleisen P, Chow JH, Anders M, Boyd CM, Kaplowitz JS, Sun K, Terrin M, Rock P. High-Flow Nasal Cannula Oxygen in Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy: HIFLOW-ENDO, a Randomized Clinical Trial. Anesth Analg. 2021 Mar 1;132(3):743-751. doi: 10.1213/ANE.0000000000004837.

  PMID: 32398433 RESULT

• Shih CC, Liang PC, Chuang YH, Huang YJ, Lin PJ, Wu CY. Effects of high-flow nasal oxygen during prolonged deep sedation on postprocedural atelectasis: A randomised controlled trial. Eur J Anaesthesiol. 2020 Nov;37(11):1025-1031. doi: 10.1097/EJA.0000000000001324.

  PMID: 32890016 RESULT

• Itagaki T, Okuda N, Tsunano Y, Kohata H, Nakataki E, Onodera M, Imanaka H, Nishimura M. Effect of high-flow nasal cannula on thoraco-abdominal synchrony in adult critically ill patients. Respir Care. 2014 Jan;59(1):70-4. doi: 10.4187/respcare.02480. Epub 2013 Jun 4.

  PMID: 23737548 RESULT

• Kagan I, Hellerman-Itzhaki M, Neuman I, Glass YD, Singer P. Reflux events detected by multichannel bioimpedance smart feeding tube during high flow nasal cannula oxygen therapy and enteral feeding: First case report. J Crit Care. 2020 Dec;60:226-229. doi: 10.1016/j.jcrc.2020.08.005. Epub 2020 Aug 22.

  PMID: 32882605 RESULT

• Coudroy R, Frat JP, Ehrmann S, Pene F, Terzi N, Decavele M, Prat G, Garret C, Contou D, Bourenne J, Gacouin A, Girault C, Dellamonica J, Malacrino D, Labro G, Quenot JP, Herbland A, Jochmans S, Devaquet J, Benzekri D, Vivier E, Nseir S, Colin G, Thevenin D, Grasselli G, Assefi M, Guerin C, Bougon D, Lherm T, Kouatchet A, Ragot S, Thille AW; REVA Network. High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol. BMJ Open. 2019 Aug 10;9(8):e029798. doi: 10.1136/bmjopen-2019-029798.

  PMID: 31401603 RESULT

• Mauri T, Galazzi A, Binda F, Masciopinto L, Corcione N, Carlesso E, Lazzeri M, Spinelli E, Tubiolo D, Volta CA, Adamini I, Pesenti A, Grasselli G. Impact of flow and temperature on patient comfort during respiratory support by high-flow nasal cannula. Crit Care. 2018 May 9;22(1):120. doi: 10.1186/s13054-018-2039-4.

  PMID: 29743098 RESULT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: March 22, 2022
• Study Start: February 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-04

Locations

IT (1)